Regulatory Divergence and Convergence in the Age of Megaregionals
Edited by Shin-yi Peng, Han-Wei Liu and Ching-Fu Lin
Chapter 15: Harmonization without localization: Trendspotting pharmaceutical patent law in recent FTAs
This chapter will analyze common pharmaceutical patent law provisions appearing in recent free trade agreements with a view to distilling the main purpose and effect of those provisions. The call for coherence between regulations in differing countries encompasses intellectual property laws and potentially impacts health policy, including access to medicines. The trend is clearly to both maximalist standards and harmonization of regulations. Existing literature is extensive on the types of ‘TRIPS-plus’ measures being incorporated into free trade agreements. This chapter will not simply decry this trend but instead makes the more nuanced argument that while harmonization can potentially yield benefits there are dangers to harmonization/regulatory coherence in the area of pharmaceutical patents. In some cases, harmonization will help efficiency and effectiveness but in other instances such standards tend to ignore context and result in inappropriate and misplaced rules. In the main, the chapter argues regulations which increase normative standards should be carefully tailored to the specific context of the country at issue while harmonization of practical standards could reduce costs and increase efficiencies in the public health system.
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